Class II · Moderate risk
Lyophilized Human Chorionic Gonadotropin 5
Lack of Sterility Assurance.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Lyophilized Sermorelin w/ GHRP2 3 mg For injection
Lack of Sterility Assurance.
Class II · Moderate risk
Lyophilized Human Chorionic Gonadotropin 5
Lack of Sterility Assurance.
Class II · Moderate risk
Lyophilized Chorionic Gonadotropin 11
Lack of Sterility Assurance.
Class II · Moderate risk
del Nido Cardioplegia Solution
Lack of Assurance of Sterility; bags have potential to leak
Class II · Moderate risk
Amino Acid Injection 50 g/1000 mL
Lack of Assurance of Sterility; bags have potential to leak
Class II · Moderate risk
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9%…
GMP Deviations: potential glass contamination
Class II · Moderate risk
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9%…
GMP Deviations: potential glass contamination
Class II · Moderate risk
PF-Fentanyl Citrate
GMP Deviations: potential glass contamination
Class II · Moderate risk
Leucovorin Calcium Injection
Crystallization: Presence of particulate matter identified as API crystallization
Class II · Moderate risk
Rifampin for Injection
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Class II · Moderate risk
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection
Lack of Assurance of Sterility: Bag has the potential to leak.
Class II · Moderate risk
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution
Lack of sterility assurance.
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Estradiol tablets
Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Class II · Moderate risk
Vivitrol (naltrexone for extended-release injectable suspension)
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Class II · Moderate risk
Pioglitazone Hydrochloride Tablets USP 15 mg
Superpotent
Class II · Moderate risk
DrKids Himasal Natural Nasal Saline Solution
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
DrKids Children's Natural Cough Syrup English Ivy Leaf
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Prednisolone Sodium Phosphate Oral Solution
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Class II · Moderate risk
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx…
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).